Sjogren’s Disease (SjD), Idiopathic Inflammatory Myopathy (IIM) Musculoskeletal Diseases
Conditions
Interventions
Generic drug name / active substance:
OM336 (INN pending
recombinant humanized bispecific antibody directed at BCMA and CD3).
Treatment Arms
OM336 is administered in 3 multiple ascending dose (MAD) cohorts and 3 expansion cohorts as summarized below:
Coho
all participants receive active OM336.
Duration of entire intervention period:
Up to four weeks of screening + four weeks of dosing + 48 weeks of safety follow-up = total ~56 weeks per participant.
Sponsors
Ouro Medicines Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of active seropositive autoimmune disease 2. Relapsed/refractory after =2 prior/ongoing treatments 3. Body weight = 50 kg 4. Willing to comply with and study requirements and procedures
Exclusion criteria
Exclusion criteria: 1. Previous treatment with a BCMA-targeted therapy 2. Clinically significant infection within 3 months of screening 3. Major surgery within 3 months of screening or planned during the study 4. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, defined as the incidence and severity of treatment-emergent adverse events (TEAEs) measured through participant reports, clinical assessments, and laboratory tests, and graded for severity using CTCAE at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability, defined as the incidence and severity of treatment-emergent adverse events (TEAEs), measured through participant reports, clinical assessments, and laboratory tests, and graded for severity using CTCAE at 52 weeks 2. To assess the pharmacokinetics (PK) of OM336 measured from scheduled patient samples analyzed using validated bioanalytical assays at 12 weeks 3. Detection of anti-drug antibodies measured from scheduled patient samples analyzed using validated bioanalytical assays at 12 weeks | — |
Countries
Australia, New Zealand
Contacts
Public ContactSarah Maddux
Outcome results
None listed